- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04565665
Cord Blood-Derived Mesenchymal Stem Cells for the Treatment of COVID-19 Related Acute Respiratory Distress Syndrome
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment Acute Respiratory Distress Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To assess the safety of administering cord blood derived mesenchymal stem cell (CB-MSC) infusions for treatment of COVID-19 acute respiratory distress syndrome (ARDS).
SECONDARY OBJECTIVES:
I. In the group of patients who present intubated on ventilator support, assess the proportion that are able to be successfully extubated.
II. In the group of patients who present requiring supplemental oxygen but otherwise breathing without assistance, assess the rate of progression to intubation.
III. Estimate the survival rate at day 30 post treatment separately by group.
IV. Determine the treatment effect on clinical parameters, oxygenation and respiratory parameters:
IVa. Resolution of fever. IVb. Changes in oxygen demand (increased oxygen saturation at similar fraction of inspired oxygen [FiO2] or decreased FiO2 requirement).
IVc. Progression to mechanical ventilation. IVd. Length of mechanical ventilation. IVe. Decrease in positive end-expiratory pressure (PEEP) in intubated patients. IVf. Decrease in FiO2 in intubated patients.
V. Determine the treatment effect on laboratory markers:
Va. Complete blood count. Vb. C-reactive protein (CRP). Vc. Ferritin. Vd. D dimer. Ve. Procalcitonin. Vf. Cytokine levels. VI. Estimate hospitalization and intensive care unit (ICU) stay. VII. Report on study related adverse events.
OUTLINE:
Currently not shipping cells outside of MD Anderson Cancer Center in Houston.
PILOT STUDY: Patients receive MSCs intravenously (IV) over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.
PHASE II STUDY: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive MSCs IV over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.
ARM II: Patients receive standard of care.
After completion of study treatment, patients are followed up at days 7, 14, 30, 60, and months 6 and 12.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Bethany Overman
- Phone Number: 713-745-4567
- Email: BJSpears@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Bethany J. Overman
- Phone Number: 713-745-4567
- Email: BJSpears@mdanderson.org
-
Principal Investigator:
- Amanda Olson
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with moderate to severe ARDS per Berlin criteria secondary to COVID-19. Moderate to severe is defined in appendix as the following: moderate partial pressure of arterial oxygen (PaO2)/FiO2 of 100-200 mm Hg, severe PaO2/FiO2 of less than 100 mm Hg
- Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
- Patient or legally authorized representative consent
- Because of the nature of COVID-19, patients enrolled on this study with COVID-19 associated ARDS may have been previously enrolled in other Investigational New Drug (IND) trials for their cancer diagnosis or COVID-19. These enrollments will not exclude them from enrollment to this study
Exclusion Criteria:
- Moribund patients not expected to survive up to 48 hours
- Patients with severe chronic liver disease (Childs-Pugh score > 10)
- Pregnant and/or lactating women
- Patients on extracorporeal membrane oxygenation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase II Arm I (mesenchymal stem cells)
Patients receive MSCs as in the Pilot study.
|
Given IV
Other Names:
|
Active Comparator: Phase II Arm II (standard of care)
Patients receive standard of care.
|
Receive standard of care
Other Names:
|
Experimental: Pilot study (mesenchymal stem cells)
Patients receive MSCs IV over 1-2 hours on day 1.
Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.
|
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of composite serious adverse events (Phase I)
Time Frame: Within 30 days of the first mesenchymal stem cell (MSC) infusion
|
Serious adverse events with be comprised of grade 3 or 4 graft versus host disease or death and will be estimated and reported overall and by group, along with 95% confidence intervals.
|
Within 30 days of the first mesenchymal stem cell (MSC) infusion
|
Patients alive without grade 3, 4 infusional toxicity (Phase II)
Time Frame: At day 30 post MSC infusion
|
At day 30 post MSC infusion
|
|
Patients alive with grade 3 or 4 infusional toxicity (Phase II)
Time Frame: At day 30 post MSC infusion
|
At day 30 post MSC infusion
|
|
Patients not alive (Phase II)
Time Frame: At day 30 post MSC infusion
|
At day 30 post MSC infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of successfully extubated patients who present intubated on ventilator support (Phase I)
Time Frame: Up to day 30 post MSC infusion
|
Will be estimated and reported with 95% confidence intervals.
|
Up to day 30 post MSC infusion
|
Rate of successful progression to intubation in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)
Time Frame: Up to day 30 post MSC infusion
|
Will be estimated and reported with 95% confidence intervals.
|
Up to day 30 post MSC infusion
|
Overall survival rate (Phase I)
Time Frame: At day 30 post MSC infusion
|
Will be estimated and reported with 95% confidence intervals.
|
At day 30 post MSC infusion
|
Survival rate in patients who present intubated on ventilator support (Phase I)
Time Frame: At day 30 post MSC infusion
|
Will be estimated and reported with 95% confidence intervals.
|
At day 30 post MSC infusion
|
Survival rate in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)
Time Frame: At day 30 post MSC infusion
|
Will be estimated and reported with 95% confidence intervals.
|
At day 30 post MSC infusion
|
Clinical parameters (Phase I)
Time Frame: Up to day 30 post MSC infusion
|
The effect of MSCs on clinical parameters will be assessed.
Continuous clinical parameters will be summarized by means, medians, standard deviations, ranges, and quartiles.
Categorical parameters will be summarized by frequency tables.
|
Up to day 30 post MSC infusion
|
Oxygenation parameters (Phase I)
Time Frame: Up to day 30 post MSC infusion
|
The effect of MSCs on oxygenation parameters will be assessed.
Continuous oxygenation parameters will be summarized by means, medians, standard deviations, ranges, and quartiles.
Categorical parameters will be summarized by frequency tables.
|
Up to day 30 post MSC infusion
|
Respiratory parameters (Phase I)
Time Frame: Up to day 30 post MSC infusion
|
The effect of MSCs on respiratory parameters will be assessed.
Continuous respiratory parameters will be summarized by means, medians, standard deviations, ranges, and quartiles.
Categorical parameters will be summarized by frequency tables.
|
Up to day 30 post MSC infusion
|
Laboratory markers (Phase I)
Time Frame: Up to day 30 post MSC infusion
|
The effect of MSCs on laboratory markers will be assessed.
Continuous laboratory parameters will be summarized by means, medians, standard deviations, ranges, and quartiles.
Categorical parameters will be summarized by frequency tables.
|
Up to day 30 post MSC infusion
|
Hospitalization stay (Phase I)
Time Frame: Up to day 30 post MSC infusion
|
Up to day 30 post MSC infusion
|
|
Intensive care unit stay (Phase I)
Time Frame: Up to day 30 post MSC infusion
|
Up to day 30 post MSC infusion
|
|
Incidence of infusion-related adverse events (Phase I)
Time Frame: Up to day 30 post MSC infusion
|
All grades of infusion-related adverse events will be summarized by grade and type.
|
Up to day 30 post MSC infusion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amanda Olson, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Disease
- Infant, Newborn, Diseases
- Occupational Diseases
- Lung Injury
- Infant, Premature, Diseases
- Neoplasms
- COVID-19
- Syndrome
- Infections
- Communicable Diseases
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Laboratory Infection
Other Study ID Numbers
- 2020-0365 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-06741 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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